May 7, 2026 · Ken Armstrong
45 CFR 164.524(c)(3)(ii) sets the expectation for individual-directed transmission. The text is brief; the evidence it implies is not, and the difference between the two is where most remediation time goes.
If an individual's request for access directs the covered entity to transmit the copy of protected health information directly to another person designated by the individual, the covered entity must provide the copy to the person designated by the individual. The individual's request must be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of protected health information.
That is the operative language of 45 CFR 164.524(c)(3)(ii). Read it closely: it describes an outcome to achieve, not a product to buy, which is why two practices of the same size can satisfy it in different ways and both be right.
In an assessment, 45 CFR 164.524(c)(3)(ii) is not one question. It resolves into several, and each one is really asking for a different artifact:
Ownership usually sits with the compliance owner, though the evidence is often produced by someone else, which is where the trail breaks. A control that works but has no owner tends to stop working the month the person who quietly maintained it changes roles.
Every covered entity. Business associates are directly liable for only a defined subset of these obligations, so read your business associate agreement alongside the rule rather than assuming the duty transfers. There is no scalability defense here of the kind the Security Rule offers at 45 CFR 164.306(b): a deadline is a deadline at any size. What does scale is how you meet it, and 45 CFR 164.530(i) expects your policies to be designed for the size and activities of your organization.
The sequence below is the order that produces evidence as a by-product rather than as a separate documentation exercise:
The same evidence answers more than one framework. The questions behind 45 CFR 164.524(c)(3)(ii) also map to HITRUST 13.g; NIST Privacy CT.DM-P2, CT.DM-P6; GDPR Art 20. That matters for scoping: if you are working toward SOC 2 or an ISO certification alongside HIPAA, this control is one piece of work and several answers, provided the artifact is written once and referenced rather than rewritten per framework.
For this requirement the artifact types that satisfy it are policy. The distinction matters more than it looks: a policy states what you intend to do, a procedure states how, and a record proves it happened on a date. Auditors ask for all three, and a practice that has written the first two often has nothing for the third.
Date every artifact and keep the superseded versions. The Privacy Rule carries its own retention rule at 45 CFR 164.530(j)(2): six years from the date of creation or the date when it last was in effect, whichever is later. It is the same period the Security Rule sets at 164.316(b)(2)(i), under a different provision, so cite the one that governs the document you are holding.
This requirement carries critical weight in an assessment, which means a gap here tends to surface as a high finding rather than an observation. The usual cause is drift: the control was implemented once, the environment changed, and nothing re-checked it. A dated review on a fixed cadence is cheaper than the remediation.
None of this makes individual-directed transmission harder than it is. The requirement asks for a decision, an implementation, and a record. Organizations that struggle at assessment time are rarely the ones without controls; they are the ones that cannot show when a control started or who owns it now.